A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
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ClinicalTrials.gov Identifier: NCT05034952 |
Recruitment Status :
Completed
First Posted : September 5, 2021
Last Update Posted : December 7, 2022
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Condition or disease | Intervention/treatment | Phase |
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Acute Pain | Drug: VX-548 Drug: HB/APAP Drug: Placebo (matched to VX-548) Drug: Placebo (matched to HB/APAP) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 303 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-dose Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty |
Actual Study Start Date : | August 30, 2021 |
Actual Primary Completion Date : | December 5, 2021 |
Actual Study Completion Date : | December 21, 2021 |
Arm | Intervention/treatment |
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Experimental: VX-548
Participants will be randomized to receive different dose levels of VX-548.
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Drug: VX-548
Tablets for oral administration. Drug: Placebo (matched to HB/APAP) Placebo matched to HB/APAP for oral administration. |
Active Comparator: Hydrocodone bitartrate/ acetaminophen (HB/APAP)
Participants will receive HB/APAP.
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Drug: HB/APAP
Capsules for oral administration. Drug: Placebo (matched to VX-548) Placebo matched to VX-548 for oral administration. |
Placebo Comparator: Placebo
Participants will receive placebos matched to VX-548 and HB/APAP.
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Drug: Placebo (matched to VX-548)
Placebo matched to VX-548 for oral administration. Drug: Placebo (matched to HB/APAP) Placebo matched to HB/APAP for oral administration. |
- Time-weighted sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) at Rest 0 to 48 Hours (SPIDr0-48) After the First Dose of Study Drug [ Time Frame: 0 to 48 Hours After the First Dose of Study Drug ]
- Time-weighted SPID as Recorded on an NPRS at Rest 0 to 24 Hours (SPIDr0-24) After the First Dose of Study Drug [ Time Frame: 0 to 24 Hours After the First Dose of Study Drug ]
- Proportions of Participants With >=30 Percent (%), >=50%, and >=70% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug [ Time Frame: At 48 Hours After the First Dose of Study Drug ]
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to Day 17 ]
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
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Before Surgery:
- Participant scheduled to undergo an abdominoplasty without collateral procedures
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After Surgery:
- Participant is lucid and able to follow commands
- All analgesic guidelines were followed during and after the abdominoplasty
- Abdominoplasty procedure duration <=3 hours without collateral procedures (for example., liposuction)
Key Exclusion Criteria
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Before Surgery:
- Prior history of abdominoplasty, intra-abdominal and/or pelvic surgery
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- Any prior surgery within 1 month before the first study drug
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After Surgery:
- Participant had medical complications during the abdominoplasty that, in the opinion of the investigator, should preclude randomization
- Participant had collateral procedures during the abdominoplasty
Other protocol defined inclusion/exclusion criteria may apply
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05034952
United States, Arizona | |
Arizona Research Center | |
Phoenix, Arizona, United States, 85053 | |
United States, California | |
Lotus Clinical Research | |
Pasadena, California, United States, 91105 | |
United States, Maryland | |
Chesapeake Research Group | |
Pasadena, Maryland, United States, 21122 | |
United States, Ohio | |
Midwest Clinical Research Center | |
Dayton, Ohio, United States, 45417 | |
United States, Texas | |
First Surgical Hospital | |
Bellaire, Texas, United States, 77401 | |
Endeavor Clinical Trials | |
San Antonio, Texas, United States, 78229 | |
United States, Utah | |
JBR Clinical Research | |
Salt Lake City, Utah, United States, 84107 |
Responsible Party: | Vertex Pharmaceuticals Incorporated |
ClinicalTrials.gov Identifier: | NCT05034952 |
Other Study ID Numbers: |
VX21-548-102 |
First Posted: | September 5, 2021 Key Record Dates |
Last Update Posted: | December 7, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Acute Pain Pain Neurologic Manifestations Acetaminophen Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics |